Ohio Code 3725.05 – Federal requirements for collection of plasma
No plasmapheresis center shall be certified by the director of health unless all federal requirements for the collection of plasma by plasmapheresis under the “Public Health Service Act,” 58 Stat. 682 (1944) 42 U.S.C. § 201, as amended, are met and:
Terms Used In Ohio Code 3725.05
- Another: when used to designate the owner of property which is the subject of an offense, includes not only natural persons but also every other owner of property. See Ohio Code 1.02
- Donor: The person who makes a gift.
- Person: includes an individual, corporation, business trust, estate, trust, partnership, and association. See Ohio Code 1.59
- Plasma: means the fluid portion of blood that has been stabilized against clotting, and is collected by plasmapheresis;
(B) "Plasmapheresis" means a procedure in which blood is drawn from a donor, the plasma is separated from the formed elements, and the formed elements are returned to the donor during a single visit to the plasmapheresis center, but excludes such a procedure performed for the purpose of improving the health of the donor;
(C) "Plasmapheresis center" means a blood bank or other establishment except a hospital that collects plasma. See Ohio Code 3725.01
(A) A test approved by the director of health for hepatitis B antigen is made on a sample of blood taken from the donor at the time of blood collection;
(B) No person who has ever shown a positive test for hepatitis B antigen or who has a history of hepatitis serves as a donor for plasma, with the exception of plasma intended for special purposes approved by the director of health;
(C) A qualified licensed physician, known as the medical director, is responsible for compliance with this chapter and rules adopted thereunder, and for maintaining the health and safety of participants in the plasmapheresis procedure;
(D) One of the following individuals is in attendance at all times when a donor is undergoing plasmapheresis and is responsible for supervising the procedure and the maintenance of sterile technique:
(1) A physician authorized under Chapter 4731 of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery;
(2) A licensed practical nurse or registered nurse as defined in section 4723.01 of the Revised Code;
(3) An individual who is certified as an emergency medical technician-intermediate or emergency medical technician-paramedic under Chapter 4765 of the Revised Code, but is not attending or supervising the procedure or maintaining sterile technique in the individual’s capacity as an emergency medical technician;
(4) Another qualified medical staff person, including a medical technologist, approved by the director of health.
(E) Handwashing facilities are present in the room where the blood is drawn and in the room where the formed elements are separated from the plasma.
Last updated July 31, 2023 at 4:51 PM